Caraco Recalls Tramadol Tablets Due to Foreign Metoprolol Contamination
Caraco is recalling Tramadol HCl 50 mg tablets because a customer reported finding Metoprolol Tartrate tablets in a bottle.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as receiving the wrong medication) are rated as Severe (4).
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling 2,264 bottles of Tramadol Hydrochloride Tablets, USP 50 mg (NDC 57664-377-18). The recall was initiated after a customer complaint indicated that a bottle of Tramadol contained some tablets of Metoprolol Tartrate Tablets, USP, 50 mg.
The affected product is Lot # GKK1373 with an expiration date of 09/13. The tablets were manufactured by Sun Pharmaceuticals Industries in India and distributed by Caraco Pharmaceutical Laboratories in Detroit, Michigan. The distribution pattern for the recalled units is nationwide.
Consumers who have this product should stop using it and contact their pharmacist or Caraco Pharmaceutical Laboratories for instructions on how to return the product. The FDA classifies this recall as Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Prescription Medication
- Affected units
- 2,264
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 (2)
- Lot # GKK1373
- Exp 09/13
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Caraco Pharmaceutical Laboratories, Ltd.
See all →- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Practice 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 →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02