The Recall Desk

Manufacturer

Cipla USA, Inc.

23 recalls in our database name Cipla USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
23
Critical
3
Severe
2
Most recent
2026-07-08

Of the 23 recalls from Cipla USA, Inc. we have scored against our rubric, 3 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–23 of 23

  • SevereFDA (Drugs)·D-0675-2026·2026-07-08

    Cinacalcet Tablets Recalled for cGMP Deviations

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg due to cGMP deviations involving the presence of N-nitroso-cinacalcet above acceptable daily intake levels.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0676-2026·2026-07-08

    Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0661-2026·2026-07-08

    Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 30 mg tablets due to the presence of N-nitroso-cinacalcet above the acceptable daily intake. The affected product was distributed nationwide.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    Cipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 60 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 96,096 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0423-2026·2026-04-15

    Cipla lanreotide prefilled syringes recalled over visual inspection deficiencies

    Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes for lack of assurance of sterility, following an FDA observation of deficiencies in visual inspection at the contract manufacturing site.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0422-2026·2026-04-15

    Cipla lanreotide syringes with safety needle recalled over sterility assurance

    Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes supplied with a safety needle, citing lack of assurance of sterility. 54,583 syringes are affected.

    Product
    LANREOTIDE ACETATE — LANREOTIDE ACETATE (LANREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0381-2026·2026-03-11

    Nilotinib capsules recalled after failing appearance tests at six months

    Cipla USA is recalling three lots of Nilotinib Capsules 150 mg after out-of-specification results in description and visual appearance testing at six-month long-term stability.

    Product
    NILOTINIB — NILOTINIB (NILOTINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0382-2026·2026-03-11

    Nilotinib 200 mg capsules recalled after failing appearance tests

    Cipla USA is recalling one lot of Nilotinib Capsules 200 mg after out-of-specification results in description and visual appearance testing at six-month long-term stability.

    Product
    NILOTINIB — NILOTINIB (NILOTINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0291-2026·2026-01-28

    Diclofenac topical gel recalled after failing pH specifications

    Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 1% after the batch failed pH specifications.

    Product
    DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0225-2026·2025-12-17

    Frozen garlic cloves recalled after testing positive for Salmonella

    Chetak New York is recalling Deep-brand frozen garlic cloves after the product tested positive for Salmonella. The FDA has classified the action as Class I.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0218-2026·2025-12-17

    Frozen jamun recalled after the product tested positive for Salmonella

    Chetak New York is recalling Deep-brand frozen jamun after the product tested positive for Salmonella. The FDA has classified the action as Class I.

    Product
    LANTHANUM CARBONATE — LANTHANUM CARBONATE (LANTHANUM CARBONATE)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0226-2026·2025-12-17

    Cinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits

    Cipla USA is recalling 12,576 bottles of Cinacalcet Hydrochloride Tablets, 90 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2026·2025-12-17

    Cinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits

    Cipla USA is recalling 63,504 bottles of Cinacalcet Hydrochloride Tablets, 30 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0217-2026·2025-12-17

    Lanthanum carbonate tablets recalled in a second hardness specification failure

    Cipla USA is recalling 1,180 boxes of Lanthanum Carbonate chewable tablets, 1000mg, from a further lot after an out of specification hardness test result.

    Product
    LANTHANUM CARBONATE — LANTHANUM CARBONATE (LANTHANUM CARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0541-2025·2025-07-30

    Budesonide inhalation ampoules recalled after leakage and empty ampoule complaint

    Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0044-2025·2024-11-20

    Lanthanum Carbonate Chewable Tablets Recalled for Crushed and Broken Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets (1000mg) distributed nationwide due to complaints of crushed and broken tablets that fail manufacturing specifications.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0043-2025·2024-11-20

    Lanthanum Carbonate 1000mg Chewable Tablets Recalled for Broken and Crushed Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg due to complaints of crushed and broken tablets. The recall affects 1,875 boxes distributed nationwide.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0471-2024·2024-05-01

    Prescription respiratory drug recalled for short fill in unit-dose vials

    Cipla USA recalls Ipratropium Bromide and Albuterol Sulfate inhalation solution due to short fill in unit-dose vials. Some vials contain less medication than labeled, affecting dosage.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0938-2023·2023-07-19

    Prescription albuterol inhalers recalled nationwide due to defective valve seals

    Cipla USA is recalling 278,538 albuterol sulfate inhalers nationwide with specific lot numbers due to defective valve gaskets that cause empty inhalers or medication leakage. Check your lot number and contact your healthcare provider if affected.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cipla

Indian multi-national pharmaceutical and biotechnology company

Country
India
Founded
1935

Official website

Source: Wikidata (Q905572), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.