Caraco Recalls Metformin HCl ER Tablets Due to Foreign Tablet Presence
Caraco Pharmaceutical is recalling 2,528 bottles of Metformin HCl ER 500 mg tablets because a customer reported finding Gabapentin tablets in the bottle.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe. While no injury is explicitly reported, the presence of a different drug (Gabapentin) in a Metformin bottle is a significant safety hazard that fits the Severe criteria for drug mix-ups.
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling 2,528 bottles of Metformin HCl Extended-Release Tablets, USP, 500 mg. The product is distributed nationwide and was manufactured by Sun Pharmaceutical Inc. Ltd. in India. The specific batch involved is JKM2433A, with a manufacturing date of 04/2013 and an expiration date of 03/2016.
The recall was initiated due to a customer complaint reporting the presence of foreign tablets, specifically Gabapentin, found inside a bottle of Metformin HCl ER. This constitutes a mix-up of different prescription medications.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Prescription Drug
- Affected units
- 2,528
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch JKM2433A
- Mfg Date 04/2013
- Exp 03/2016
UPCs (2)
- 0362756142015
- 0362756143012
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · METFORMIN HYDROCHLORIDE
- ModerateMetformin Hydrochloride Extended-Release Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
- HighMetformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-04-02
- SevereMetformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2022-02-02
- HighMetformin Hydrochloride Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2021-06-30
- ModerateSun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance
FDA (Drugs) · 2021-05-19
Same manufacturer · Caraco Pharmaceutical Laboratories, Ltd.
See all →- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-07-09
- SevereCaraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-07-02
- ModerateCaraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-05-07
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateSun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Substance
FDA (Drugs) · 2021-05-19
- SevereCaraco Recalls Tramadol Tablets Due to Foreign Metoprolol Contamination
FDA (Drugs) · 2012-12-12
- ModerateSun Pharmaceutical Recalls Metformin Hydrochloride Tablets Due to Foreign Matter
FDA (Drugs) · 2018-07-25
- HighGabapentin 600 mg Tablets Recalled Due to Metformin Contamination
FDA (Drugs) · 2024-08-14
- ModerateAurobindo Recalls Metformin Hydrochloride Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2018-02-28
- HighMetformin ER 500 mg tablets recalled due to foreign tablet contamination
FDA (Drugs) · 2025-01-15