The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 288 (18%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all cgmp deviation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

976–1000 of 1563

  • ModerateFDA (Drugs)·D-0013-2021·2020-09-16

    Teva Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Teva Pharmaceuticals is recalling Cephalexin for Oral Suspension because current Good Manufacturing Practice deviations may cause active ingredient levels to fall outside specification limits.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0012-2021·2020-09-16

    Teva Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Teva Pharmaceuticals is recalling specific lots of Cephalexin for Oral Suspension because current Good Manufacturing Practice deviations may cause active ingredient levels to fall outside specification limits.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1531-2020·2020-08-26

    Calvin Scott Recalls Phentermine Tablets Due to Packaging Deviations

    Calvin Scott & Company is recalling specific lots of Phentermine HCL tablets because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

    Product
    Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1523-2020·2020-08-26

    Calvin Scott Recalls Phendimetrazine Capsules Due to Packaging Deviation

    Calvin Scott & Co. is recalling specific lots of Phendimetrazine capsules because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1517-2020·2020-08-26

    Calvin Scott Recalls Thyroid 1 Grain Tablets Due to Packaging Defects

    Calvin Scott & Co. is recalling specific lots of Thyroid 1 Grain Tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

    Product
    Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1384-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1383-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1386-2020·2020-07-22

    Granules Pharmaceuticals Recalls Metformin Hydrochloride Extended-Release Tablets

    Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets due to FDA detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    METFORMIN — METFORMIN (METFORMIN ER 500 MG)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1390-2020·2020-07-22

    Preferred Pharmaceuticals Recalls Lidothol Patches Due to Missing Batch Records

    Preferred Pharmaceuticals is recalling Lidothol Patches because the contract manufacturer misplaced or lost batch records and test results.

    Product
    Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1334-2020·2020-07-01

    Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1353-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1349-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1333-2020·2020-07-01

    PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling 1,969 bottles of Metformin Hydrochloride Extended Release 500 mg because FDA analysis detected NDMA impurity above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1347-2020·2020-07-01

    Amneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1352-2020·2020-07-01

    Amneal Metformin Hydrochloride Extended-Release Tablets Recalled for NDMA Impurity

    Amneal Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1305-2020·2020-06-24

    AvKARE Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    AvKARE Inc. is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulas
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1280-2020·2020-06-03

    CVS Lidocaine Cold and Hot Patch Recalled for Manufacturing Record Loss

    CVS Pharmacy is recalling Maximum Strength Lidocaine Cold & Hot Patches because manufacturing records and samples were lost, meaning the product may not remain within specification through its expiration date.

    Product
    Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1279-2020·2020-06-03

    Mencaine Lidocaine Patches Recalled Due to Missing Manufacturing Records

    Wuhan Bingbing Pharmaceutical is recalling Mencaine patches because manufacturing records and samples were lost, preventing verification that the product remains within specification through expiration.

    Product
    Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1260-2020·2020-05-13

    Teva Recalls Epinephrine Auto-Injectors Due to CGMP Deviations

    Teva Pharmaceuticals is recalling Epinephrine Injection USP auto-injectors due to out-of-specification trigger force. The product was not distributed to the public.

    Product
    EPINEPHRINE — EPINEPHRINE (EPINEPHRINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1100-2020·2020-04-15

    Teva Recalls Losartan Potassium Tablets Due to Impurity Detection

    Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets because an impurity was detected in the active pharmaceutical ingredient.

    Product
    LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1119-2020·2020-04-15

    Herbal Doctor Remedies Recalls Detoxin Ex Capsules for CGMP Deviations

    Herbal Doctor Remedies is recalling Detoxin Ex capsules because the products were found to be misbranded as unapproved new drugs due to CGMP deviations.

    Product
    Detoxin Ex, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1012-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Regular Strength Acid Reducer (Ranitidine) tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1024-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Potential Impurity Contamination

    Perrigo is recalling specific lots of Maximum Strength Acid Reducer ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1019-2020·2020-03-25

    Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination

    Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.

    Product
    Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pha
    Category
    Drug
    Distribution
    Distributed nationwide